Umbilical cord clamp and cutter

ABSTRACT

A novel umbilical cord clamp and a combined umbilical cord clamp and cutter are provided for clamping and cutting umbilical cords in one motion. The cutter comprises two shells joined by a longitudinal hinge. A transverse blade is mounted in one shell, and a cutting support is mounted in the other shell across from the blade. A clamping member is provided on one side of the blade as part of the cutter, and a removable clamp is provided on the other side of the blade. The umbilical cord to be cut is oriented generally parallel to the hinge and lying across the cutting support. As the shells of the cutter are closed, the umbilical cord is clamped on both sides of the blade, and the blade severs the umbilical cord in the same motion. After the cut is completed, the removable clamp is removed from the cutter, preferably revealing an aesthetically pleasing form such as the face of a koala bear.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] This invention relates generally to umbilical cord clamps andcutters, and more particularly to a combined umbilical cord clamp andcutter for clamping and cutting an umbilical cord in one continuousmotion.

[0003] 2. Description of the Related Art

[0004] A number of clamps and cutters are known in the art for clampingand cutting the umbilical cords of newborn babies. Perhaps the mostcommon clamp currently used for such purposes is the umbilical cordclamp disclosed in U.S. Pat. No. 4,212,303, issued to Nolan on Jul. 15,1980 and assigned to Hollister Incorporated (“the Hollister clamp”). TheHollister clamp comprises a pair of flexible arms joined by an integralhinge to form a generally V-shaped clamp. The interior of each arm hasserrations or ridges for grasping the umbilical cord. The free end ofone of the arms has a flexible tongue that cooperates with a recess onthe free end of the other arm to close the clamp about the umbilicalcord. In practice, two Hollister clamps are clamped to the umbilicalcord in spaced relation to one another, and the cord is then cut betweenthe two clamps using scissors or a scalpel. One clamp is temporarilyleft on the baby's navel, and the other clamp is disposed of with theplacenta. The Hollister clamp has several drawbacks. First, it takesthree separate instruments (two clamps and a cutting tool) to accomplishthe process of cutting the umbilical cord using the Hollister clamp. Inan alternative practice, one Hollister clamp is frequently used inconjunction with a hemostat, and the cord is cut between the Hollisterclamp and the hemostat. If a hemostat is used instead of a secondHollister clamp during the cutting process, the overall procedure iseven more cumbersome because the hemostat is typically replaced with asecond Hollister clamp after the cord is cut, which adds a fourthinstrument. Second, the Hollister clamp does not provide any shield fromthe splatter of blood when the umbilical cord is cut, which presents adanger of blood-borne pathogens to hospital personnel. Additionally, theHollister clamp is not aesthetically attractive when left on the baby'snavel.

[0005] Several combined clamp and cutter devices have been developedthat essentially employ the Hollister clamp. An example of one suchdevice is shown in U.S. Pat. No. 5,925,052, issued to Simmons on Jul.20, 1999 (“Simmons”). Simmons discloses a scissor-type device with acutting blade that receives an assembly comprising a pair ofHollister-type clamps. As the scissors are squeezed together, the bladesevers the umbilical cord and the clamp assembly while closing the twoclamps on either side of the cut. Although the Simmons device combinesthe two clamps and cutter into a single tool, it does not solve theproblem of the need for a shield to guard against the splatter of bloodnor the problem of poor aesthetics. A similar device is also disclosedin U.S. Pat. No. 5,968,054, issued to Yeatts et al. on Oct. 19, 1999,which suffers from the same disadvantages.

[0006] U.S. Pat. No. 5,697,938, issued to Jensen et al. on Dec. 16, 1997(“Jensen”), discloses a disposable device for squeezing and cutting anumbilical cord comprising a pair of clamps that mate with a sliding unitwhich contains a blade. As the sliding unit closes the clamps, the bladesevers the umbilical cord. Again, however, the Jensen device does nothave a shield to prevent the splatter of blood, and the clamps aremodifications of the Hollister clamp which are not aestheticallyappealing.

[0007] U.S. Pat. No. 5,676,672, issued to Watson et al. on Oct. 14, 1997(“Watson”), addressed the problem of the splatter of blood by housing acutting blade and a circular clamping surface inside a cooperating pairof semi-cylinders joined by a hinge. A similar pair of semi-cylinderswith a second circular clamping surface is connected to the first pairof semi-cylinders with a breakable joint. As the two pair ofsemi-cylinders are closed in clamshell fashion, the clamping surfacescompress the umbilical cord. Thereafter, the blade is depressed to severthe cord, and the semi-cylinders prevent the blood from splattering.Then, the two pair of semi-cylinders are separated by breaking thebreakable joint. The pair of semicylinders without the blade is leftwith the baby, and the other pair is discarded with the placenta.Although the Watson device solved the blood splatter problem, the pairof semi-cylinders left with the baby is bulky and aestheticallyunattractive. Additionally, although the Watson device was intended toenable one-handed operation, the Watson device presents significantdifficulties in the process of depressing the blade and breaking theclamps apart.

[0008] Thus, a need exists for a disposable umbilical cord clamp andcutter that prevents the splatter of blood, is easy to operate with onehand, and leaves an aesthetically pleasing clamp on the baby's navel

SUMMARY OF THE INVENTION

[0009] To solve the problems mentioned above, a cutter device inaccordance with the present invention comprises a pair of shellsconnected by a longitudinal hinge. The first shell has a transverseblade fixedly mounted therein and a clamping member adjacent the bladeon the “mother” side of the blade. The second shell has a cuttingsupport aligned with the blade. The cutter is positioned with theumbilical cord lying across the cutting support, which preferablycomprises a pair of walls separated by a gap into which the blade maypass. On the “baby” end of the cutter, a removable clamp is insertedbetween the shells. The removable clamp has a clamp body with acorrugated clamping surface, a strap for cooperating with the clampingsurface, and a hinge joining the strap to the clamp body. The clamp bodyhas a crown opposite the clamping surface for engagement with theinterior surface of the first shell, and the exterior surface of thestrap engages the interior surface of the second shell. Thus, as the twoshells are closed, the clamping member in the first shell of the cuttercompresses the umbilical cord on the “mother” side of the blade, theclamping surface of the removable clamp compresses the umbilical cordagainst the strap of the removable clamp on the “baby” side of theblade, and the blade severs the umbilical cord, all in one motionthrough the action of one hand of the user.

[0010] As the umbilical cord is severed as described above, the shellssubstantially surround the cord and thereby prevent the splattering ofblood. Preferably, the clamping member in the first shell has at leastone tab for engagement with a catch extending from the second shell.More preferably, two tabs are provided for engagement with the catch.Together, the tabs and catch constitute a latch to keep the shellsclosed after the cut is complete. Toward the end of the closing of theshells, the first tab clicks into engagement with the catch to indicatethat the shells are prevented from reopening. Upon further squeezing ofthe shells, the second tab clicks into engagement with the catch toindicate that the cut is complete. Also, each shell is preferablyprovided with a guide that engages the guide of the other shell to forma detent that holds the shells in a partially open initial positionbefore the cutting process is begun. The exterior of each shell ispreferably provided with a plurality of protrusions or recesses toassist the user in gripping the cutter. Together, the shells have anoverall outer shape that comfortably fits in the palm of the user'shand.

[0011] In the vicinity where the removable clamp is mounted to theshells of the cutter, the periphery of each shell is provided with anindentation to allow access to a protrusion of the removable clamp.After the umbilical cord is severed, the user may use a thumb to apply aforce to the protrusion of the removable clamp in order to dislodge theremovable clamp from the shells. The removable clamp is then left withthe baby, and the cutter is discarded with the placenta. The removableclamp is preferably shaped like the head of a koala bear, with facialindicia (e.g., eyes, nose, and mouth) on the face. When the removableclamp is engaged with the shells of the cutter, the face of the koalabear is toward the interior of the cutter. After the removable clamp isremoved from the cutter, the baby is left with a clamp on its navel thatresembles a koala bear, which is much more attractive than a Hollisterclamp. Therefore, the removable clamp of the present invention isaesthetically pleasing as well as very practical. The removable clampmay also be made in the shape of various other animals, such as a teddybear or duck, or other non-animal shapes, such as an ellipse.

[0012] In addition, the removable clamp is preferably provided with arecess on the back side of the clamp body. The recess provides forreduced weight of the clamp and tends to eliminate sink marks if theclamp is manufactured by a molding process. Also, the recess allows fora wireless transmitter to be inserted in the clamp so that the baby canbe tracked electronically.

[0013] It is an object of the present invention to provide a combinedumbilical cord clamp and cutter for clamping and cutting an umbilicalcord in one motion.

[0014] It is a further object of the present invention to provide adisposable umbilical cord clamp and cutter that prevents the splatter ofblood or other fluids when cutting an umbilical cord.

[0015] It is another object of this invention to provide a combinedumbilical cord clamp and cutter that is easily and safely operable withone hand.

[0016] It is still another object of this invention to provide animproved umbilical cord clamp that is aesthetically pleasing.

[0017] Further objects and advantages of the present invention will bereadily apparent to those skilled in the art from the following detaileddescription taken in conjunction with the annexed sheets of drawings,which illustrate a preferred embodiment of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1 is a perspective view of an umbilical cord cutter andremovable clamp in accordance with the present invention shown in aclosed position.

[0019]FIG. 2 is an exploded perspective view of the umbilical cordcutter of FIG. 1 shown in an open position.

[0020]FIG. 3 is another perspective view of the umbilical cord cutter ofFIG. 1 shown in an open position.

[0021]FIG. 4 is yet another perspective view of the umbilical cordcutter and removable clamp of FIG. 1 shown in an open position withoutthe blade.

[0022]FIG. 5 is still another perspective view of the umbilical cordcutter and removable clamp of FIG. 1 shown in an open position withoutthe blade.

[0023]FIG. 6 is a front elevational view of the umbilical cord cutter ofFIG. 1 shown in an open position.

[0024]FIG. 7 is a front elevational view of the umbilical cord cutter ofFIG. 1 shown in a closed position.

[0025]FIG. 8 is a top view of the umbilical cord cutter of FIG. 1 shownin an open position.

[0026]FIG. 9 is a sectional view taken along line 9-9 of FIG. 8.

[0027]FIG. 10 is a sectional view similar to FIG. 9 but with theumbilical cord cutter in a closed position.

[0028]FIG. 11 is a sectional view taken along line 11-11 of FIG. 8.

[0029]FIG. 12 is a sectional view taken along line 12-12 of FIG. 8.

[0030]FIG. 13 is a perspective view of the removable clamp of FIG. 1shown in an open position.

[0031]FIG. 14 is a front elevational view of the removable clamp of FIG.1 shown in an open position.

[0032]FIG. 15 is a front elevational view of the removable clamp of FIG.1 shown in a closed position.

[0033]FIG. 16 is a rear elevational view of the removable clamp of FIG.1 shown in a closed position.

[0034]FIG. 17 is a sectional view taken along line 17-17 of FIG. 16.

[0035]FIG. 18 is a perspective view illustrating the use of theumbilical cord cutter and removable clamp of FIG. 1.

[0036]FIG. 19 is a sectional view similar to FIG. 17 showingdisplacement of the face of the removable clamp.

[0037]FIG. 20 is a sectional view taken along line 20-20 of FIG. 15.

[0038]FIG. 21 is a perspective view of an alternative umbilical cordcutter with two removable clamps in accordance with the presentinvention shown in an open position.

[0039]FIG. 22 is a sectional view taken along line 22-22 of FIG. 16.

[0040]FIG. 23 is a sectional view taken along line 23-23 of FIG. 16.

[0041]FIG. 24 is a sectional view taken along line 24-24 of FIG. 16.

[0042]FIG. 25 is a perspective view of another alternative umbilicalcord cutter and clamp in accordance with the present invention.

[0043]FIG. 26 is an exploded perspective view of the umbilical cordcutter and clamp of FIG. 25.

[0044]FIG. 27 is a front elevational view of the clamp of FIG. 25.

[0045]FIG. 28 is a perspective view of yet another alternative umbilicalcord cutter and clamp in accordance with the present invention.

[0046]FIG. 29 is an exploded perspective view of the umbilical cordcutter and clamp of FIG. 28.

[0047]FIG. 30 is a front elevational view of the clamp of FIG. 28.

[0048]FIG. 31 is a perspective view of still another alternativeumbilical cord cutter and clamp in accordance with the presentinvention.

[0049]FIG. 32 is an exploded perspective view of the umbilical cordcutter and clamp of FIG. 31.

[0050]FIG. 33 is a front elevational view of one embodiment of the clampof FIG. 31.

[0051]FIG. 34 is a front elevational view of another embodiment of theclamp of FIG. 31.

[0052]FIG. 35 is a front elevational view of yet another embodiment ofthe clamp of FIG. 31.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

[0053] Referring primarily to FIGS. 1-6, a cutter 10 in accordance withthe present invention comprises a first shell 12 joined to a secondshell 14 by a longitudinal hinge 16. Preferably, hinge 16 is integralwith shells 12 and 14, but shells 12 and 14 could be made separately andjoined with a separate hinge. As discussed further below, a removablebaby clamp 100 is installed on one end of cutter 10. Baby clamp 100 isnot shown in FIGS. 2, 3, and 6 for the sake of clarity. A blade 40 istransversely mounted to the inside of shell 12 with a blade holder 30,which extends from the inner surface of shell 12 Blade 40, which ispreferably made of surgical steel about 0.03 in. thick, is not shown inFIGS. 4 and 5 for the sake of clarity. The end of cutter 10 to whichbaby clamp 100 is mounted is referred to as the “baby end,” and theother end is referred to as the “mother end.” As best seen in FIG. 2,blade holder 30 preferably comprises two upstanding walls 32 and 34connected by a support member 36. Additional support members 38 a and 38b are provided to stabilize the inner and outer ends of blade 40, and aplurality of gussets 39 are provided to further strengthen and stiffenblade holder 30. Blade 40 contains a slot 42 such that blade 40straddles support member 36. Tooling holes 44 are provided to facilitatethe installation of blade 40 by pressing it into blade holder 30.

[0054] On the inside of shell 14 opposite blade 40, a cutting support 50is provided to support an umbilical cord (not shown) while the cord isbeing cut by blade 40. Cutting support 50 preferably comprises a pair ofupstanding walls 52 separated by a gap 58 into which blade 40 protrudesas the cord is being cut. The width dg of gap 58 (best shown in FIG. 8)is preferably about 0.06 in. If width dg is too wide (for example,greater than about 0.125 in.), blade 40 will tend to press the umbilicalcord into gap 58 rather than cut through the umbilical cord. Walls 52preferably have relatively sharp upper edges 56 to help preventlongitudinal movement of the umbilical cord during the cutting process.Buttresses 54 a-d may be provided to strengthen and stiffen walls 52 andto serve as lateral constraints to help prevent excessive lateralmovement of the umbilical cord. The “V” shape of walls 52 also helps tokeep the umbilical cord properly positioned for cutting.

[0055] On the mother side of blade 40, a clamping member 20 extendstransversely from shell 12. Preferably, clamping member 20 has aplurality of teeth 26 for engaging the umbilical cord, and clampingmember 20 preferably cooperates with a plurality of ridges 18 formed onthe inside of shell 14 opposite clamping member 20. Ridges 18 may beconnected by a central ridge 19. Clamping member 20 is preferablystabilized by a plurality of gussets 23.

[0056] To keep cutter 10 closed after the umbilical cord has beensevered, a pair of tabs 22, 24 is provided on clamping member 20 forcooperation with a catch 60 that depends from shell 14. As the cut isbeing performed, first tab 22 will click into engagement with catch 60,which prevents shells 12 and 14 from accidentally coming open.Thereafter, upon further squeezing of shells 12 and 14, tab 24 willclick into engagement with catch 60 to indicate that the cut has beencompleted. In addition to providing a locking function, the clicking oftabs 22 and 24 into engagement with catch 60 provides audible andtactile indications to the user that shells 12 and 14 are restrictedfrom reopening and that the cut has been completed. An opening 84 ispreferably created in shell 14 by a protrusion of the mold used to formcatch 60. If for some reason cutter 10 needs to be opened after theumbilical cord has been severed, opening 84 provides access to theinterior of cutter 10 so that catch 60 may be deflected outward andthereby disengaged from tabs 22 and 24. Alternatively, catch 60 may beaccessed for such purpose through the opening between shells 12 and 14at the mother end of cutter 10. A plurality of bumps 86, oralternatively depressions, may be provided on shells 12 and 14 tofacilitate grasping by the user.

[0057] To facilitate installation and removal of baby clamp 100 to andfrom cutter 10, slots 74 and 76 are provided on the baby end of shell 12to form a flexible shelf 66, and slots 78 and 80 are provided on thebaby end of shell 14 to form a flexible shelf 68. A plurality of nibs 82are provided on shelves 66 and 68 for cooperation with recesses 138 onbaby clamp 100, as best shown in FIG. 14, to retain baby clamp 100 oncutter 10. Guides 28, 160, and 162 also help to properly position babyclamp 100 with respect to cutter 10. Shells 12 and 14 and baby clamp 100are preferably sized such that shelves 66 and 68 exert a slightcompressive force on baby clamp 100 when cutter 10 is in a closedposition. Short fences 70 and 72 are preferably provided just insideshelves 66 and 68, respectively, to prevent baby clamp 100 from slidingtoo far into the interior of cutter 10. Indentations 88 and 90 areprovided in shells 12 and 14, respectively, to facilitate removal ofbaby clamp 100 after the umbilical cord has been cut by allowing theuser to place a thumb behind an ear 128 of baby clamp 100 and dislodgebaby clamp 100 from cutter 10.

[0058] To hold shells 12 and 14 in a partially open initial position asshown in FIGS. 4 and 5, cooperating guides 62 and 64 are provided onshells 12 and 14, respectively. Guides 62 and 64, which preferably haverounded or chamfered nibs 92 that allow initial engagement of guides 62and 64 and that cause guides 62 and 64 to bear against one another asshells 12 and 14 are closed during the cutting process, serve as adetent to prevent shells 12 and 14 from opening up excessively so thatcutter 10 may be easily handled in order to properly position anumbilical cord therein. Such an initial position is also a preferredstarting position from which to begin the cutting process. A cutout 65is provided in shells 12 and 14 to accommodate guides 62 and 64 whenshells 12 and 14 are closed.

[0059]FIGS. 6 and 7 illustrate the relationship of blade 40 to clampingmember 20 and cutting support 50 in open and closed cutter positions,respectively. As shown in FIG. 6, blade 40 (including the pointed tip ofblade 40) is shallower than imaginary arc 46 of clamping member 20 atall points such that clamping member 20 will begin to engage theumbilical cord before blade 40 does so as cutter 10 is closed.Additionally, the recession of blade 40 below clamping member 20 helpsto prevent medical personnel from being cut while handling cutter 10.Although cutter 10 may be made in any suitable size, in order toaccommodate umbilical cords ranging from about 5 to 20 mm in diameter,the radius of arc 46 is preferably about 0.62 in., the distance S_(c)along arc 46 is preferably about 1.3 in., the depth d_(t) of teeth 26 ispreferably about 0.08 in., the distance S_(t) between successive teeth26 along arc 46 is preferably about 0.22 in., the combined total ofdistances d₁, d₂, d₃, and d₄ is preferably about 1.6 in., and thethickness T_(c) of clamping member 20 (best shown in FIG. 11) ispreferably about 0.05 in. If T_(c) is too thin, clamping member 20 wouldtend to cut the umbilical cord rather than pinch it as desired; if T_(c)is too thick, clamping member 20 would tend to crush the umbilical cord.Almost immediately after clamping member 20 begins to engage theumbilical cord, the blood flow within the umbilical cord begins todecrease as the umbilical cord is constricted and cut. Thisphysiological phenomenon helps to reduce the amount of blood that isavailable to squirt out of the umbilical cord during the cuttingprocess. The blood that does squirt out of the umbilical cord during thecutting process is trapped by shells 12 and 14, which preventssplattering of blood and thereby improves cleanliness of the operatingroom and reduces the risk of blood born diseases to persons in theoperating room. As shown in FIG. 7, blade 40 protrudes all the way pastedges 56 of walls 52 of cutting support 50 to accomplish a clean,complete severance of the umbilical cord. Because blade 40 is shallowerthan clamping member 20 and clamping surface 108, and because edges 56of cutting support 50 are elevated above the interior surfaces of shell14 and strap 104 with which clamping member 20 and clamping surface 108respectively cooperate to compress the umbilical cord on either side ofblade 40, clamping member 20 and clamping surface 108 place theumbilical cord in tension across cutting support 50, which furtherenhances the cutting performance of blade 40 by pulling the cord apartat the cut.

[0060] FIGS. 8-10 illustrate the relationship of clamping member 20 toridges 18 and 19 and also the relationship of tabs 22 and 24 to catch 60and opening 84. As shown in FIG. 8, clamping member 20 is longitudinallyaligned with ridge 19, which is centered on ridges 18. FIGS. 9 and 10show the lateral cross-section of cutter 10 through clamping member 20,ridges 18, and catch 60 with cutter 10 in an open and closed position,respectively. As shown in FIG. 10, in the closed position, tab 24 isengaged with catch 60 to prevent shells 12 and 14 from openinginadvertently, and clamping member 20 is brought to a position in whicha small gap 166 exists between clamping member 20 and shell 14. Theumbilical cord (not shown) is compressed within gap 166 and is heldfirmly in place by teeth 26 and ridges 18. Gap 166 is sized such thatthe umbilical cord is compressed sufficiently so as to completely shutoff the flow of blood within the umbilical cord. Preferably, toaccommodate umbilical cords ranging from about 5 to 20 mm in diameter,gap 166 is sized such that the distance d₅ (from the roots of teeth 26to the interior surface of shell 14) is about 0.15 in., the distance d₆(from the tips of teeth 26 to the interior surface of shell 14) is about0.07 in., and the distance d₇ (from the interior surface of shell 14 tothe tips of ridges 18) is about 0.03 in.

[0061]FIG. 11 shows a longitudinal cross-section of shell 12 passingthrough clamping member 20, blade holder 30, and fence 70. As seen inFIG. 11, shell 12 preferably has a slight longitudinal curvature as wellas lateral curvature for ease in handling. Similarly, FIG. 12 shows alongitudinal cross-section of shell 14 passing through ridges 18, 19,walls 52 of cutting support 50, fence 72, and nub 82. Shell 14preferably has a thickened area 168 in the vicinity of ridges 18, 19 andwalls 52 of cutting support 50 to eliminate the longitudinal curvatureon the interior of shell 14 at ridges 18, 19 so that ridges 18, 19better cooperate with clamping member 20 and to increase the strengthand stiffness of cutting support 50. Like shell 12, shell 14 preferablyhas a slight longitudinal curvature as well as lateral curvature forease in handling.

[0062] As shown in FIGS. 13-17, baby clamp 100 comprises a clamp body102 and a strap 104 connected by a hinge 106. Clamp body 102 preferablyhas a corrugated clamping surface 108 for clamping the umbilical cord incooperation with the inner surface 122 of strap 104, which preferablyhas a plurality of ridges 124 to help grip the umbilical cord. To saveweight, clamp body 102 preferably has a central cavity 154 bounded byclamping surface 108 and a crown 134. When baby clamp 100 is installedin cutter 10, back surface 158 faces away from cutter 10 (as best shownin FIG. 1) and face 156 faces toward the interior of cutter 10 (as bestshown in FIG. 4). At the end of strap 104 opposite hinge 106, strap 104has an ear 128 with a slot 130 for receiving a hook 110 that dependsfrom clamp body 102 opposite hinge 106. Hook 110 has a catch 112 thatcooperates with a recess 132 (best seen in FIGS. 4 and 5) for holdingbaby clamp 100 in the closed position. The thickness of hook 110preferably varies from about 0.06 in. at dimension d₈ to about 0.04 in.at dimension d₉, and the width W_(L) of hook 110 (best shown in FIG. 20)is preferably about 0.13 in. Hook 110 preferably subtends an angle θ_(L)of about 117 degrees with an inner arc length of about 0.31 in. As shownin FIG. 20, the overall thickness T_(L) of ear 128 and hook 110 ispreferably about 0.09 in. Hinge 106 preferably has an arc length S_(H)of about 0.68 in. Crown 134 and strap 104 preferably have a plurality ofrecesses 138 for cooperating with nubs 82 on shelves 66, 68 to hold babyclamp 100 in cutter 10. Ridges 114 and 136, which depend from clamp body102, cooperate with ridges 120 and 126 of strap 104 to close the gapbetween clamp body 102 and strap 104 in the vicinity of hinge 106 andear 128 when baby clamp 100 is closed. A curved closeout 118 ispreferably provided on the end of strap 104 adjacent hinge 106 to helpprevent the umbilical cord from slipping into hinge 106. For symmetry, asimilar closeout 146 may be provided on ear 128. When baby clamp 100 isclosed, the umbilical cord will lie compressed in the gap 174 betweenstrap 104 and clamp body 102 and will be held firmly in place byclamping surface 108 and ridges 124. To accommodate umbilical cordsranging from about 5 to 20 mm in diameter, radius R_(s) of strap 104 ispreferably about 0.56 in., and distance S_(s) between ridges 120 and 126along the interior surface 122 of strap 104 is preferably about 1.08 in.Tooling holes 140 may be provided to help remove baby clamp 100 from itsmold during manufacturing. The exterior surfaces of crown 134 and strap104 preferably have a plurality of recesses 142 to help the user gripbaby clamp 100. As is readily apparent from the drawings, when babyclamp 100 is closed, a preferred shape of baby clamp 100 resembles thehead of a koala bear. Accordingly, face 156 of clamp body 102 may beprovided with protrusions that form a pair of eyes 148, a nose 150, anda mouth 152. Cavity 154 may also be utilized to house a sensor (notshown) for tracking the location of the baby after baby clamp 100 hasbeen installed.

[0063] Preferably, cutter 10 and baby clamp 100 are each molded as asingle piece of material. Alternatively, cutter 10 and baby clamp 100may be machined or manufactured according to other methods known in theart. Although a variety of materials may be used, the preferred materialis polycarbonate, which may be translucent and may be manufactured in avariety of colors. Because cutter 10 is intended to be a disposableproduct, hinge 16 need not be capable of many openings and closings ofshells 12 and 14. The present inventors have found that hinge 16 ispreferably about 0.02 in. thick if polycarbonate material is used. Indescribing the best mode of practicing this invention, a number ofdimensions are disclosed herein for various features of the invention.However, it should be recognized that such dimensions, likepolycarbonate material, are simply preferred, and this invention is notlimited to the dimensions or materials described herein.

[0064] In order to accommodate umbilical cords ranging from about 5 to20 mm in diameter, baby clamp 100 is designed such that clamp body 102moves toward the interior of cutter 10 during the clamping process. Inthat regard, the angle 178 between clamping surface 108 and clamp body102 is preferably slightly more than 90 degrees. This obtuse angle 178also helps in removing baby clamp 100 from the mold duringmanufacturing. Similar to teeth 26 on clamping member 20, thecorrugations of clamping surface 108 also assist in accommodating cordsof varying size. As an umbilical cord is being clamped, the upwardpressure on clamping surface 108 causes torsional displacement of hinge106 such that the lower edge of clamp body 102 moves away from strap 104as shown in FIG. 19. This design of baby clamp 100 is such that, afterthe umbilical cord has been cut and baby clamp 100 is left on theinfant's navel, pulling of baby clamp 100 in a direction away from theinfant generally serves to tighten the grip of baby clamp 100 on thestub of the cord, which helps to prevent inadvertent removal of babyclamp 100 from the infant. As illustrated in FIG. 20, gaps having adistance d₁₀ of preferably about 0.05 in. are provided between ridges120 and 136 and ridges 126 and 114 to allow clamp body 102 to move ashinge 106 flexes. For proper flexure, hinge 106 preferably has athickness T_(h) of about 0.06 in. and a width W_(h) of about 0.25 in. Asshown in FIGS. 17 and 19, the lower edge of clamp body 102 preferablyhas a thickness T_(f) of about 0.08 in. to properly pinch the umbilicalcord. As with clamping member 20 discussed above, if T_(f) is too thin,clamp body 102 would tend to cut the umbilical cord rather than pinch itas desired; if T_(f) is too thick, clamp body 102 would tend to crushthe umbilical cord.

[0065]FIGS. 17, 22, 23, and 24 illustrate preferred distances betweenstrap 104 and clamp body 102 when baby clamp 100 is in the closedposition in order to snugly clamp umbilical cords ranging from about 5to 20 mm in diameter. Specifically, distances d₁₁ through d₂₂ preferablyhave the following approximate dimensions:

[0066] d₁₁≈0.08 in.;

[0067] d₁₂≈0.06 in.;

[0068] d₁₃≈0.11 in.;

[0069] d₁₄≈0.04 in.;

[0070] d₁₅≈0.06 in.;

[0071] d₁₆≈0.07 in.;

[0072] d₁₇≈0.12 in.;

[0073] d₁₈≈0.05 in.;

[0074] d₁₉≈0.15 in.;

[0075] d₂₀≈0.03 in.;

[0076] d₂₁≈0.04 in.;

[0077] d₂₂≈0.06 in.

[0078] Distances d₁₁, d₁₄, d₁₇, d₂₀ are average distances from ridges124 to clamping surface 108 in view of the slight inclination ofclamping surface 108 at angle 178 as discussed above.

[0079] The use of cutter 10 and baby clamp 100 in cutting an umbilicalcord 164 is illustrated in FIG. 18. Umbilical cord 164 is placed inshell 14 so that umbilical cord 164 is generally centered in the “V” ofwalls 52 on cutting support 50. Cutter 10 and baby clamp 100 areoriented such that arrow 170 is toward the mother and arrow 172 istoward the baby. Once the umbilical cord 164 is thus placed, shell 12 isrotated about hinge 16 toward shell 14, and shelf 66 of shell 12 therebyrotates body 102 of baby clamp 100 about hinge 106 toward strap 104,which is supported by shelf 68 of shell 14. As shell 12 approaches shell14, clamping member 20 engages cord 164 on the mother side of blade 40,and clamping surface 108 engages cord 164 on the baby side of blade 40.As the closing of cutter 10 and baby clamp 100 upon cord 164 continues,clamping member 20 and ridges 18, 19 (best shown in FIG. 3) firmly claspcord 164 on the mother side of blade 40, and clamping surface 108 andridges 124 firmly clasp cord 164 on the baby side of blade 40, whichputs cord 164 in tension across cutting support 50. In the same closingmotion, blade 40 severs cord 164 as blade 40 is forced into gap 58between walls 52 of cutting support 50. The cutting performance isenhanced by the tension in cord 164, as discussed above. At the end ofthe closing motion, tabs 22 and 24 successively click into engagementwith catch 60 to indicate that the cut is complete. After completion ofthe cut, the user removes baby clamp 100 from cutter 10 by placing hisor her thumb 176 in the gap behind ear 128 formed by indentations 88 and90 and forcing baby clamp 100 out of engagement with shelves 66, 68. Thebaby is then left with an aesthetically pleasing koala bear on itsnavel. Thus, the clamping and cutting of the umbilical cord 164 and theseparation of the baby clamp 100 from the cutter 10 are easilyaccomplished with one hand of the user. Preferably, cutter 10 and babyclamp 100 are placed as close as possible to the baby before the cuttingprocess is begun so that baby clamp 100 will be essentially adjacent thebaby's tummy after the process is completed. Cutter 10 remains clampedto cord 164, which preserves the blood within cord 164 to be sent to thelaboratory with the placenta (not shown) for any testing that may benecessary. Ultimately, cutter 10 is discarded along with cord 164 andthe placenta.

[0080] The preferred embodiment shown in the drawings is designedprimarily for right-handed use. It will be apparent to those skilled inthe art that cutter 10 and removable baby clamp 100 may be made in themirror image of that shown in the accompanying drawings for left-handeduse. However, the present inventors have found that the configurationshown in the drawings is generally preferred by both right-handed andleft-handed users.

[0081] Preferably, cutter 10 and baby clamp 100 are providedpre-assembled in the open position within a sterile package. Althoughthe primary use of baby clamp 100 is in conjunction with cutter 10 asdescribed above, baby clamp 100 may also be used to clamp an umbilicalcord separate from cutter 10. Additionally, as shown in FIG. 21, thepresent invention may comprise a cutter 200 with two removable clamps100 and 210, one on each end of shells 212 and 214. After cutter 200 hasbeen used to sever the umbilical cord, both clamps 100 and 210 may beremoved from cutter 200; clamp 100 remains with the infant, and clamp210 remains with the cord and placenta.

[0082] The removable clamp of this invention may also be made in thelikeness of animals other than koala bears and in other non-animalshapes. For example, FIGS. 25-27 illustrate an umbilical cord cutter 220in accordance with this invention having a circular blade 224 and a pairof removable clamps 222 in the shape of a teddy bear head. Similarly,FIGS. 28-30 illustrate an umbilical cord cutter 230 in accordance withthis invention having a circular blade 234 and a pair of removableclamps 232 in the shape of a duck head, and FIGS. 31-35 illustrate anumbilical cord cutter 240 in accordance with this invention having anelliptical blade 244 and a removable clamp 242 in the shape of anellipse that may be made to resemble a mouse (FIG. 33), a cat (FIG. 34),or an owl (FIG. 35). Thus, although the preferred shape is that of akoala bear, the removable clamp of this invention may take on many othershapes.

[0083] Although the foregoing specific details describe a preferredembodiment of this invention, persons reasonably skilled in the art willrecognize that various changes may be made in the details of thisinvention without departing from the spirit and scope of the inventionas defined in the appended claims. Therefore, it should be understoodthat this invention is not to be limited to the specific details shownand described herein.

We claim:
 1. A device for clamping and cutting an umbilical cord, saiddevice comprising: a first shell; a second shell movably connected tosaid first shell; a blade depending from said first shell, said bladehaving a first side and a second side; a cutting support depending fromsaid second shell; a clamping member depending from said first shell,said clamping member being located on said first side of said blade; anda removable clamp engageable with said first and second shells, saidremovable clamp being located on said second side of said blade; saiddevice being capable of receiving the umbilical cord adjacent saidcutting support; said first and second shells being capable of closingmovement such that (a) said clamping member will compress the umbilicalcord in cooperation with said second shell on said first side of saidblade, (b) said removable clamp will compress the umbilical cord on saidsecond side of said blade, and (c) said blade will sever the umbilicalcord in cooperation with said cutting support; said removable clampbeing separable from said first and second shells after the umbilicalcord is severed.
 2. The device of claim 1 wherein said first shell, saidsecond shell, said cutting support, and said clamping member comprise asingle integral structure.
 3. The device of claim 2 wherein said singleintegral structure comprises a polycarbonate material.
 4. The device ofclaim 1 further comprising a latch for holding said first and secondshells in a closed position after the umbilical cord is severed.
 5. Thedevice of claim 1 further comprising a first guide depending from saidfirst shell and a second guide depending from said second shell whereinsaid first and second guides cooperate to hold said first and secondshells in a partially open initial position for receiving the umbilicalcord.
 6. The device of claim 1 wherein said cutting support comprises apair of walls separated by a gap into which said blade may pass as theumbilical cord is being severed.
 7. The device of claim 1 furthercomprising at least one lateral constraint depending from said secondshell for limiting lateral movement of the umbilical cord as theumbilical cord is being severed.
 8. The device of claim 1 wherein saidremovable clamp resembles the head of an animal.
 9. The device of claim8 wherein said removable clamp resembles the head of a koala bear. 10.The device of claim 1 wherein each of said first and second shells hasan exterior surface and wherein at least one of said first and secondshells comprises a plurality of protrusions on its exterior surface toassist a user in grasping said device.
 11. The device of claim 1 whereineach of said first and second shells has an exterior surface and whereinat least one of said first and second shells comprises a plurality ofrecesses on its exterior surface to assist a user in grasping saiddevice.
 12. The device of claim 1 wherein at least one of said first andsecond shells comprises a flexible shelf for engaging said removableclamp.
 13. The device of claim 1 wherein said second shell comprises aplurality of ridges for cooperation with said clamping member tocompress the umbilical cord.
 14. The device of claim 1 wherein saidclamping member comprises a plurality of teeth for engaging theumbilical cord.
 15. The device of claim 1 wherein said removable clampcomprises a clamp body, a strap, a hinge connecting said clamp body tosaid strap, and a latch for holding said clamp body and said strap in aclosed position with the umbilical cord compressed between said clampbody and said strap.
 16. The device of claim 15 wherein said clamp bodycomprises a corrugated clamping surface for engaging the umbilical cord.17. The device of claim 15 wherein said strap comprises a plurality ofridges for engaging the umbilical cord.
 18. The device of claim 15wherein said removable clamp further comprises a closeout adjacent saidhinge to prevent the umbilical cord from binding in said hinge.
 19. Thedevice of claim 15 wherein said clamp body comprises a recess in which atransmitter is installed for transmitting a signal that may be used totrack the location of said removable clamp.
 20. The device of claim 1wherein said removable clamp comprises a polycarbonate material.
 21. Adevice for clamping an umbilical cord, said device comprising: a clampbody having a face surface, a back surface, and an arcuate clampingsurface; an arcuate strap; a hinge connecting said clamp body to saidstrap; and a latch for holding said clamp body and said strap in aclosed position with the umbilical cord compressed between said clampingsurface and said strap.
 22. The device of claim 21 wherein said clampbody resembles the head of an animal.
 23. The device of claim 22 whereinsaid clamp body resembles the head of a koala bear.
 24. The device ofclaim 22 wherein said face surface comprises indicia of facial featuresof said animal.
 25. The device of claim 22 wherein said hinge forms anear of said animal when said device is in said closed position.
 26. Thedevice of claim 21 wherein said back surface comprises a recess capableof receiving a transmitter for transmitting a signal that may be used totrack the location of said device.
 27. The device of claim 21 whereinsaid clamping surface comprises a plurality of corrugations.
 28. Thedevice of claim 21 wherein said strap comprises a plurality of ridgesfor engaging the umbilical cord.
 29. The device of claim 21 furthercomprising a closeout adjacent said hinge to prevent the umbilical cordfrom binding in said hinge.
 30. The device of claim 21 wherein saidclamp body, said strap, said hinge, and said latch comprise a singleintegral structure.
 31. The device of claim 30 wherein said singleintegral structure comprises a polycarbonate material.
 32. A device forclamping and cutting an umbilical cord, said device comprising: a firstshell comprising an exterior surface with a first plurality ofprotrusions for helping to grasp said device, a first flexible shelf forengaging a removable clamp, and a first guide depending from said firstshell; a second shell comprising an exterior surface with a secondplurality of protrusions for helping to grasp said device, a secondflexible shelf for engaging a removable clamp, a plurality of interiorridges for engaging the umbilical cord, a catch protruding toward theinterior of said second shell, and a second guide depending from saidsecond shell; a first hinge connecting said first and second shells,said first hinge permitting movement of said first and second shellsbetween an open position and a closed position; a blade depending fromsaid first shell, said blade having a first side and a second side; acutting support depending from said second shell, said cutting supportcomprising a pair of walls separated by a gap into which said blade maypass as said first and second shells are moved from said open positionto said closed position; at least one lateral constraint depending fromsaid second shell for limiting lateral movement of the umbilical cord; aclamping member depending from said first shell and being located onsaid first side of said blade, said clamping member comprising aplurality of teeth for engaging the umbilical cord and at least one tabfor engagement with said catch to hold said first and second shells insaid closed position; and a removable clamp engageable with said firstand second shells, said removable clamp being located on said secondside of said blade and comprising a clamp body having a face surface, aback surface, and a corrugated clamping surface, said clamp body havinga shape resembling the head of a koala bear, said face surface havingindicia of facial features of a koala bear; a strap having a pluralityof ridges for engaging the umbilical cord; a second hinge connectingsaid clamp body to said strap; a closeout depending from said strapadjacent said second hinge to prevent the umbilical cord from binding insaid second hinge; and a latch for holding said clamp body in engagementwith said strap with the umbilical cord compressed between said clampingsurface and said strap; said device being capable of receiving theumbilical cord adjacent said cutting support; wherein, as said first andsecond shells are moved from said open position to said closed position,(a) said clamping member will compress the umbilical cord in cooperationwith said second shell on said first side of said blade, (b) saidremovable clamp will compress the umbilical cord on said second side ofsaid blade, (c) said blade will sever the umbilical cord in cooperationwith said cutting support, and (d) said first and second guidescooperate to inhibit torsional displacement of said first and secondshells; wherein said removable clamp is separable from said first andsecond shells after the umbilical cord is severed.
 33. The device ofclaim 32 wherein said first shell, said second shell, said first hinge,said cutting support, said at least one lateral constraint, and saidclamping member comprise a first integral structure and wherein saidremovable clamp comprises a second integral structure.
 34. The device ofclaim 33 wherein said first and second integral structures comprise apolycarbonate material.
 35. The device of claim 32 wherein said backsurface of said clamp body comprises a recess in which a transmitter isinstalled for transmitting a signal that may be used to track thelocation of said removable clamp.